Mr. John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.
Device Changes and the 510(k) – Hardware and Software
This webinar will evaluate two recently published U.S. FDA Guidance Documents on device changes: 1) “Deciding When to Submit a 510(k) for a Change to an Existing Device Final Guidance for Industry and FDA Staff”; and 2) “Deciding When to Su ...
- Intermediate
- 90 Mins
- Jun 19, 2019
Implementing the New Usability Engineering Standard – IEC 62366-1 and IEC/TR 62366-2: Guidance on Application
Part 1, IEC 62366-1:2015, “Application of the new Usability Engineering Standard to Medical Devices”, defines a 9-stage process to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety.This usabili ...
- Intermediate
- 90 Mins
CAPA Under U.S. FDA / CGMPs and EU MDR / ISO
CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and one of the four key areas of a medical device QSIT inspection. CAPA is a key source of regulatory problems. The primary areas for CAPA focus.The roles of Fai ...
- Basic & Intermediate
- 90 Mins
Verification vs. Validation – Product¸ Process or Equipment, Software and QMS
Review a company's Verification and Validation System for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validatio ...
- Basic & Intermediate
- 90 Mins
Human Factors Engineering to Satisfy the New IEC 62366-1, -2
Part 1, IEC 62366-1:2015, “Application of the new Usability Engineering Standard to Medical Devices”, defines a 9-stage process to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability ...
- Basic & Intermediate
- 90 Mins
Powerful Closed-loop CAPA - Meeting FDA Expectations
CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) are major components of product complaint, non-conformance, and OOS failure investigations, and hazard analysis/risk management and mitigation activities, as well as ...
- Intermediate
- 90 Mins
The New Usability Engineering Standard in IEC 62366-1:2015- Application and IEC/TR 62366-2:2- Guidance on Application to Medical Devices
IEC has released a new medical device usability standard, IEC 62366-1:2015, “Usability Engineering in IEC 62366-1:2015 -- Part 1: Application of the new Usability Engineering Standard to Medical Devices” and “IEC/TR 62366-2:2 Part 2: Guidance on ...
- Intermediate
- 90 Mins
Risk-based CAPA Systems
CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance and OOS failure investigations and hazard analysis/risk management and mitigation activities, as well as produc ...
- Basic & Intermediate
- 90 Mins
DHF, DMR, DHR and Technical File / Design Dossier - Including New ISO 13485:2016 and EU MDR Requirements
This webinar will discuss the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed. Also ...
- Intermediate
- 60 Mins
10 Steps to Effectual Risk Analysis for US FDA and ISO 14971 Compliance
Expectations for meaningful hazard analysis, hazardous conditions and the resulting product risk management documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support ...
- Basic & Intermediate
- 90 Mins